Penetration of Moxifloxacin Into Liver Tissue of Patients Undergoing Liver Resection. (MOXI)

University Hospital, Saarland

Status and phase: Completed; Phase 4

Conditions: Side-effect of Antibiotic

Treatments: Drug: Moxifloxacin 400 mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01302951

24/06

2008-001902-18 (EudraCT Number)

Details and patient eligibility

About

The aim of the study is to provide data on the pharmacokinetics (PK) of moxifloxacin (MXF) in serum and liver tissue of patients undergoing liver resection due to primary or secondary tumor of the liver.

Full description

After given informed consent, patients scheduled for planned liver resection are enrolled into the study. The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection. Blood and healthy liver tissue are sampled in 34 patients after administration of MXF. Plasma is sampled concomitantly. In a subgroup of 19 patients, additional serum specimens are obtained after 2, 4, 8, 12, 24, 36 and 48 h to establish the PK. The pharmacokinetic parameters of MXF are calculated applying a two-compartment model.

Enrollment: 34 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 18-80 years old
• elective liver resection of liver tumor
• in females: pregnancy test negative
• Subjects willing and able to give fully informed written consent

Exclusion criteria

• subjects with contra-indications to Moxifloxacin
• subjects under therapy with Moxifloxacin within 2 weeks before recruitment

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Moxifloxacin

Experimental group

Description:

Moxifloxacin 400 mg i.v.

Treatment:

Drug: Moxifloxacin 400 mg

No drug

No Intervention group

Description:

2 Patients were included as controls- no MXF given